
Senior R&D Engineer - Electrophysiology
- Arden Hills, MN
- $82,600 per year
- Permanent
- Full-time
- Defines and analyzes system requirements, clinical workflows, and input/output processes by using current systems engineering methods and technologies.
- Systems engineering mindset, able to articulate customer unmet needs and translate into holistic technical solutions.
- Providing technical direction and system-level expertise across development teams working on the design and development of complex medical device systems.
- Researches, develops, designs, and evaluates: mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
- Develops solutions to diverse engineering problems using ingenuity and creativity. Leverages internal/external partners as necessary to achieve project objectives.
- Drives technical project tasks within single use device development including requirements, design, implementation, test, integration, transfer to manufacturing, and verification/validation.
- Solves system problems by analyzing the situation and recommending corrective or alternative actions. Leads technical workstreams through problem solving. Facilitates crisp decision making around key technical issues.
- Independently plans and organizes project tasks with showing the ability to prioritize tasks, execute, and direct others.
- Ensure quality system compliance for medical device development, champion continuous improvement, and adopt best practices.
- Participates in the development of others by providing coaching and guidance.
- Creates a strong team culture around high expectations and high performance
- Participates in writing and submission of intellectual property (patents).
- Maintains detailed documentation throughout all phases of research and development.
- Provides clear communication to Technical Leaders at key technical updates.
- BS degree in Mechanical Engineering
- Required minimum years of work experience (primarily in medical device or related field): 5+ Years with BS, 3+ Years with MS
- Experience managing technical aspects of projects as a member of a cross-functional core team
- Demonstrated strong cross-functional collaboration and project/task management enabling highly effective teams
- Passion for understanding and solving problems for end users
- Strong written and oral communication skills
- Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.
- Experience with electrophysiology and/or Class II or Class III Medical Device product development experience.
- Demonstrated product development leadership and communication skills.
- Demonstrated ability to provide technical leadership within a large-scale development program
- Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.
- Medical Device experience working with imaging and signal processing systems (EEG, Electrophysiology, etc.).
- Experience conducting simulations, mathematical analysis and/or system interaction analysis.
- Engineering experience in mixed HW/SW systems.
- Technical experience with digital and analog low noise systems.
- Usability engineering experience.
- Understanding of working within a quality system, IEC and ISO standards relevant to medical device lifecycle and risk management (i.e., ISO 13485).